Trial · NCT00168103
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
NCT00168103, Phase 2, Phase 3, Completed, CSL Behring; results first posted 2010-08-24
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks. Trials, record NCT00168103. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00168103
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
- NCT number
- NCT00168103
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 126 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Hereditary Angioedema
- Interventions
- C1 Esterase Inhibitor, Placebo
- First posted
- 2005-09-14
- Last updated
- 2015-03-31
- Other registries' IDs
- eudract:2004-001186-17
- Results first posted
- 2010-08-24
- Limitations and caveats
- A test for futility of the C1-INH 10 U/kg bw group conducted during a planned interim analysis led to ceasing recruitment for the C1-INH 10 U/kg bw group.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Start of Relief of Symptoms From HAE Attack | Up to 24 h after start of study treatment | The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief. |
| Secondary | Number of Subjects With Worsened Intensity of Clinical HAE Symptoms | Baseline and between 2 and 4 h after start of study treatment | Includes any worsening of intensity of at least 1 of the HAE symptoms present at baseline. Routinely checked symptoms included pain, nausea, vomiting, cramps, and diarrhea. |
| Secondary | Number of Vomiting Episodes | Within 4 h after start of study treatment | |
| Other | Time to Complete Resolution of All HAE Symptoms, Including Pain | Up to 24 h after start of study treatment | Complete resolution of symptoms was determined by subject self-assessment. |
| Other | Number of Subjects Receiving Rescue Study Medication | Within 4 h after start of study treatment |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Start of Relief of Symptoms From HAE Attack | Up to 24 h after start of study treatment | Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication. | Hours | MEDIAN |
| SECONDARY | Number of Subjects With Worsened Intensity of Clinical HAE Symptoms | Baseline and between 2 and 4 h after start of study treatment | Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication. | Subjects | NUMBER |
| OTHER_PRE_SPECIFIED | Time to Complete Resolution of All HAE Symptoms, Including Pain | Up to 24 h after start of study treatment | Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication. | Hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Subjects Receiving Rescue Study Medication | Within 4 h after start of study treatment | Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication. | Subjects | NUMBER |
| SECONDARY | Number of Vomiting Episodes | Within 4 h after start of study treatment | Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication. | Episodes per subject | MEDIAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Start of Relief of Symptoms From HAE Attack | C1-INH 10 U/kg bw | 1.17 | Full Range 10.513 | Hours | |
| Time to Start of Relief of Symptoms From HAE Attack | C1-INH 20 U/kg bw | 0.5 | Full Range 8.202 | Hours | |
| Time to Start of Relief of Symptoms From HAE Attack | Placebo | 1.5 | Full Range 11.481 | Hours | |
| Number of Subjects With Worsened Intensity of Clinical HAE Symptoms | C1-INH 10 U/kg bw | 8 | Subjects | ||
| Number of Subjects With Worsened Intensity of Clinical HAE Symptoms | C1-INH 20 U/kg bw | 2 | Subjects | ||
| Number of Subjects With Worsened Intensity of Clinical HAE Symptoms | Placebo | 13 | Subjects | ||
| Time to Complete Resolution of All HAE Symptoms, Including Pain | C1-INH 10 U/kg bw | 20.00 | Full Range 494.230 | Hours | |
| Time to Complete Resolution of All HAE Symptoms, Including Pain | C1-INH 20 U/kg bw | 4.92 | Full Range 314.347 | Hours | |
| Time to Complete Resolution of All HAE Symptoms, Including Pain | Placebo | 7.79 | Full Range 382.815 | Hours | |
| Number of Subjects Receiving Rescue Study Medication | C1-INH 10 U/kg bw | 13 | Subjects |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | C1-INH 10 U/kg bw | 40 | |
| Overall Study | STARTED | C1-INH 20 U/kg bw | 43 | |
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | STARTED | Not Randomized | 1 | |
| Overall Study | COMPLETED | C1-INH 10 U/kg bw | 38 | |
| Overall Study | COMPLETED | C1-INH 20 U/kg bw | 38 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | COMPLETED | Not Randomized | 1 | |
| Overall Study | NOT COMPLETED | C1-INH 10 U/kg bw | 2 | |
| Overall Study | NOT COMPLETED | C1-INH 20 U/kg bw | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | C1-INH 10 U/kg bw | 1 | 39 | |
| other | Abdominal pain | Gastrointestinal disorders | C1-INH 20 U/kg bw | 2 | 46 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 41 | |
| other | Diarrhea | Gastrointestinal disorders | C1-INH 10 U/kg bw | 1 | 39 | |
| other | Diarrhea | Gastrointestinal disorders | C1-INH 20 U/kg bw | 0 | 46 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 4 | 41 | |
| other | Dysgeusia | Nervous system disorders | C1-INH 10 U/kg bw | 1 | 39 | |
| other | Dysgeusia | Nervous system disorders | C1-INH 20 U/kg bw | 2 | 46 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 0 | 41 | |
| other | Edema peripheral | General disorders | C1-INH 10 U/kg bw | 1 | 39 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | C1-INH 10 U/kg bw | ||
| Total, all-cause mortality | C1-INH 20 U/kg bw | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | C1-INH 10 U/kg bw | 10 | 39 |
| Total, other adverse events | C1-INH 20 U/kg bw | 10 | 46 |
| Total, other adverse events | Placebo | 18 | 41 |
| Total, serious adverse events | C1-INH 10 U/kg bw | 0 | 39 |
| Total, serious adverse events | C1-INH 20 U/kg bw | 0 | 46 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00168103
GET https://conductscience.org/api/trials/v1/NCT00168103/events?page=2